Exelixis Reports Strong Q4 & FY25 Financials, FDA Accepts Zanzalintinib NDA, Reaffirms 2026 Guidance

summarizeSummary

Exelixis announced strong Q4 and FY2025 financial results, including significant revenue and EPS growth, while reaffirming its 2026 guidance. The FDA accepted the NDA for zanzalintinib in metastatic colorectal cancer, and the company authorized an additional $750 million stock repurchase program.

check_boxKey Events

• Strong Q4 and FY2025 Financial Performance

  Exelixis reported total revenues of $598.7 million for Q4 2025 (up from $566.8 million in Q4 2024) and $2.320 billion for FY 2025 (up from $2.169 billion in FY 2024). GAAP diluted EPS significantly increased to $0.88 for Q4 2025 (from $0.48 in Q4 2024) and $2.78 for FY 2025 (from $1.76 in FY 2024).

• FDA Accepts Zanzalintinib NDA for Metastatic CRC

  The FDA accepted the New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer, assigning a standard review with a PDUFA target action date of December 3, 2026.

• Maintained Fiscal Year 2026 Financial Guidance

  The company is maintaining its previously provided financial guidance for fiscal year 2026, with total revenues projected between $2.525 billion and $2.625 billion, and net product revenues between $2.325 billion and $2.425 billion.

• Robust Clinical Pipeline Advancement

  Exelixis detailed upcoming milestones including anticipated results from STELLAR-303 and STELLAR-304 pivotal trials in mid-2026, and planned initiations of STELLAR-316 and STELLAR-201 trials, further expanding the zanzalintinib development program.

auto_awesomeAnalysis

Exelixis delivered robust financial results for both the fourth quarter and full fiscal year 2025, with significant increases in total revenues and diluted EPS compared to the prior year. This strong performance underpins the company's decision to maintain its previously issued fiscal year 2026 financial guidance. A major pipeline advancement is the FDA's acceptance of the New Drug Application for zanzalintinib in combination with atezolizumab for previously treated metastatic colorectal cancer, marking a critical step towards potential market approval with a PDUFA target action date of December 3, 2026. The company also highlighted a robust clinical development roadmap for zanzalintinib, including new trial initiations and upcoming pivotal data readouts, alongside continued shareholder returns through an additional $750 million stock repurchase authorization.